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Treatment of High Risk Adult Acute Lymphoblastic Leukemia (LAL-AR/2003)

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ClinicalTrials.gov Identifier: NCT00853008
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : April 7, 2020
Sponsor:
Information provided by (Responsible Party):
PETHEMA Foundation

Study Description
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Brief Summary:
Current therapeutic protocols for adult ALL consider MRD together with the baseline risk factors (age, WBC count, immunophenotype, cytogenetics) and speed in response to therapy for treatment decisions. On the other hand, the systematic use of allogeneic SCT for all adult patients (pts) with Ph- HR-ALL is still a matter of debate. The aim of the prospective study ALL-AR-03 from the Spanish PETHEMA Group was to evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels (assessed by cytofluorometry at the end of induction and consolidation therapy) in HR Ph- adult ALL patients.

Condition or disease Intervention/treatment Phase
Acute Lymphoblastic Leukemia Drug: Vincristine Drug: Daunorubicin Drug: Prednisone Drug: Mitoxantrone Drug: Cytosine Arabinoside Drug: Dexamethasone Drug: Methotrexate (MTX) Drug: Cytarabine Drug: ASP Drug: Mercaptopurine Drug: Teniposide Drug: Hydrocortisone Phase 4

Detailed Description:
HR ALL included one or more of the following baseline parameters: age 30-60 yr, WBC count >25x109/L and 11q23 or MLL rearrangements. Induction therapy included vincristine, prednisone and daunorubicin for 4 weeks. In pts with slow cytologic response to therapy (≥10% blasts in bone marrow assessed on d14) intensified induction with high dose ARA-C and mitoxantrone was administered. Early consolidation therapy included 3 cycles with rotating cytotoxic drugs including high-dose methotrexate, high-dose ARA-C and high-dose asparaginase. Pts. with slow cytologic response on d14 or MRD level >0.05% after consolidation were assigned to allogeneic SCT (related or unrelated) and those with standard cytologic response on d14 and MRD level <0.05% after consolidation received 3 additional cycles of delayed consolidation (identical to those of early consolidation) followed by maintenance therapy up to 2yr in CR.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of High Risk Adult Acute Lymphoblastic Leukemia
Study Start Date : January 2003
Actual Primary Completion Date : November 2012
Actual Study Completion Date : December 2012

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Arms and Interventions
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Intervention Details:
  • Drug: Vincristine
    Vincristine (VCR): 1.5 mg/m2 (max 2 mg) IV d 1, 8, 15, 22 in induction VCR 2 mg, IV, d 1,8 in consolidation (cycle 1, 2)
  • Drug: Daunorubicin
    Daunorubicin (DNR): 60 mg/m2 IV d 1, 8, 15, 22
  • Drug: Prednisone
    Prednisone (PDN): 60 mg/m2/d IV or PO, d 1-28
  • Drug: Mitoxantrone
    Mitoxantrone:12 mg/m2, IV d 15-17 in induction 12 mg/m2, IV,d 5 in cycle 2 consolidation
  • Drug: Cytosine Arabinoside
    ARA-C 2,000 mg/m2/12h IV, d18,19 (4 doses) in induction
  • Drug: Dexamethasone
    Dexamethasone 20 mg/m2,IV, d 1-5,10 mg/m2,IV, d 6 and 5 mg/m2,IV, d 7 in Consolidation (3 cycles)
  • Drug: Methotrexate (MTX)
    Methotrexate (MTX)3 g/m2,IV, d1 (24h)in consolidation, cycles 1 and 2 MTX (15 mg/m2/wk, IM)in maintenance MTX 15 mg, IT
  • Drug: Cytarabine
    Cytarabine 2g/m2/12h, IV d5 in cycle 1 consolidation Cytarabine 2g/m2/12h, IV d 1,2 in cycle 3 consolidation Cytarabine 30 mg, intrathecal
  • Drug: ASP
    ASP 25,000 IU/m2, IV, d5 in consolidation (cycle 1, 2, 3)
  • Drug: Mercaptopurine
    Mercaptopurine 100 mg/m2, PO, d 1-5 in consolidation
  • Drug: Teniposide
    Teniposide 150 mg/m2, IV d 3,4 in consolidation cycle 3
  • Drug: Hydrocortisone
    Hydrocortisone 20 mg, IT d 1, 28, 49, 77, 105, 175, 203, 231, 259,287, 311 intrathecal

Outcome Measures
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Primary Outcome Measures :
  1. To evaluate the response to a differentiated therapy (chemotherapy or allogeneic SCT) according to early bone marrow blast clearance and MRD levels in HR Ph- adult ALL patients. [ Time Frame: 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High risk ALL adult patients (age> 15 years)no treated previously
  • High-risk ALL:

  • One or more of the following:

    • Age 30-60 yr.
    • WBC count >25x109/L
    • 11q23 or ALL1/AF4
  • Very high-risk ALL:

  • HR ALL and one or the following:

    • Slow cytologic response (>10% blasts in BM on d14 of induction therapy).
    • MRD>0.05% (by flow cytometry) at the end of consolidation

Exclusion Criteria:

  • L3 ALL or B mature(sIg +) or t(8;14), t(2;8), t(8;22).
  • ALL Ph (BCR/ABL) positive.
  • Bifenotipics ALL as EGIL criteria.
  • Indifferentiated ALL.
  • Patients with cardiac pathology
  • Patients with chronic liver disease in activity fase
  • Pulmonary disease
  • Renal insufficiency not due to ALL
  • Neurological disorders not due to ALL
  • PS (grades 3 and 4) not due to ALL.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00853008


Locations
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Sponsors and Collaborators
PETHEMA Foundation
Investigators
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Study Chair: Ribera Josep Mª, Dr PETHEMA Foundation
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: PETHEMA Foundation
ClinicalTrials.gov Identifier: NCT00853008    
Other Study ID Numbers: LAL-AR/2003
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: April 7, 2020
Last Verified: April 2020
Keywords provided by PETHEMA Foundation:
Acute Lymphoblastic Leukemia
High-Risk (HR)
Philadelphia Chromosome-Negative
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cytarabine
Dexamethasone
Prednisone
Hydrocortisone
Methotrexate
Vincristine
 Daunorubicin
Mercaptopurine
Mitoxantrone
Teniposide
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents